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Pharmaceutical Flexo Requirements
Pharmaceutical packaging demands a higher quality assurance level than any other flexo application. Patient safety, regulatory compliance, and zero-defect standards require specialized machine configurations and validation procedures.
GMP Compliance Features
- IQ/OQ/PQ validation documentation package included
- 21 CFR Part 11 compliant electronic records and audit trail
- Calibrated instruments with traceable certificates
- Cleanable stainless steel surfaces in product contact zones
Serialization and Track-and-Trace
100% vision inspection system verifies 2D DataMatrix codes and serial numbers at full production speed. System integrates with pharma track-and-trace networks (DSCSA, EU FMD compliance). Reject mechanisms automatically remove unverified units.
Ink Selection
Low-migration UV inks formulated to Nestlé Guidance and Swiss Ordinance standards prevent migration to drug products. LISHG works with certified ink suppliers to ensure regulatory compliance for each customer's specific pharmaceutical application.
